Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis.

Completed

• Conditions: Non-Cardiac Chest Pain; Undiagnosed Chest Pain; Musculoskeletal Chest Pain; Ischemic Heart Disease

• Registration Number: NCT00373828
• Lead Sponsor: Clinical Locomotion Science

Brief Summary

The overall aim of the project is to evaluate diagnosis and treatment of chest pain originating from the musculoskeletal system. Specifically, we wish to investigate prevalence and character of such chest pain in a population of patients with acute chest pain, admitted to a university hospital based acute chest pain clinic, and undergoing evaluation of acute coronary syndrome (Part 1). Then, to test a manually-based treatment protocol to patients with diagnosed musculoskeletal chest pain in a randomized clinical trial (Part 2).

The specific purpose of this study (Part 1) is to determine the exact number of patients with acute chest pain origination from the musculoskeletal system, and to describe their cardiac status with respect to ischemic heart disease. Further, we wish to evaluate the decision making process of the chiropractor.

Detailed Description

Acute chest pain is a common reason for hospital admission. The focus of diagnosis is of course pain of cardiac origin including myocardial infarction and/or other ischemic heart disease; however, in up to 50% of cases the aetiology may be non-cardiac. Differential diagnoses include primarily pulmonary, gastrointestinal, psychosocial, or musculoskeletal problems, and musculoskeletal problems may account for around 20% of the total number of admissions in acute chest pain clinics. Thus the musculoskeletal system is a recognized possible source of pain in patients with chest pain even though a confident diagnosis of musculoskeletal chest pain can be difficult to establish since no gold standard exists to verify this diagnosis.

Chest pain patients with normal coronary anatomy have an excellent prognosis for survival and a future risk of cardiac morbidity similar to that reported in the background population. However, about three quarters of patients with non-cardiac chest pain continue to suffer from residual chest pain with large socio-economic consequences. Therefore, a search for an alternative cause with related possibilities for treatment is warranted. Given these perspectives, the general objective of the present work is to study the diagnosis of chest pain originating from the musculoskeletal system of the cervical and thoracic spine, and thorax in patients with chest pain of various origins, and to evaluate ischemic heart disease status among patients with presumed musculoskeletal pain.

Evaluation:

Patients with musculoskeletal chest pain will be identified using a standardized examination protocol comprised of a semi-structured interview, a general health examination, and a specific manual examination of the muscles and joints of the neck, thoracic spine and thorax. All patients will have a Myocardial Perfusion Imaging (MPI) performed and results from the MPI will be compared with the musculoskeletal status. Specific important parameters of the standardized examination protocol will be identified and the decision making process of the chiropractor will be evaluated.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-19
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• Acute episode of chest pain of less than 7 days duration as primary reason for admission to a chest pain clinic.
• Admitted to a chest pain clinic, suspected of acute coronary infarction, but with a negative diagnosis confirmed by normal coronary enzymes and normal ECG.
• Pain arising from the thorax and/or neck.
• Able to read and understand Danish.

Exclusion Criteria

• Acute coronary syndrome.
• Percutaneous Coronary Intervention.
• Coronary Artery Bypass Grafting.
• Other disease, diagnosed during this admission, which is likely to have caused the acute episode of chest pain.
• No written consent.
• Inflammatory joint disease.
• Diabetes mellitus, type I.
• Fibromyalgia.
• Sharp trauma to the chest.
• Malignant disease.
• Apoplexy.
• Gross osseous anomalies, such as pronounced scoliosis.
• Known or suspected osteoporosis.
• Pregnancy.
• Dementia/unable to cooperate.
• Not residing in the County of Funen.
• Does not want to participate.
• Other - reason for exclusion will be noted.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Musculoskeletal chest pain	baseline	Presence of MSCP yes/no

Trial Locations

Locations (1)

The Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital; 🇩🇰 Sdr. Boulevard 29, Odense C, Denmark